The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02655887




Registration number
NCT02655887
Ethics application status
Date submitted
7/01/2016
Date registered
14/01/2016
Date last updated
16/07/2019

Titles & IDs
Public title
BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease
Scientific title
The BARD® VENOVO™ Venous Stent Study - A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease - an Assessment for Effectiveness and Safety (VERNACULAR)
Secondary ID [1] 0 0
BPV-14-007
Universal Trial Number (UTN)
Trial acronym
VERNACULAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
May-Thurner Syndrome 0 0
Peripheral Vascular Disease 0 0
Venous Disease 0 0
Iliofemoral Occlusive Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - VENOVO™ Venous Stent

Experimental: VENOVO™ Venous Stent. - Implant of the VENOVO™ Venous Stent


Treatment: Devices: VENOVO™ Venous Stent
VENOVO™ Venous stent placement

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure - Primary patency rate at 12 months post-index procedure evaluated against a literature-derived Performance Goal (PG) of 74%. Primary patency defined as: freedom from Target Vessel Revascularization (TVR); freedom from thrombus occlusion and stenosis > 50% as measured by Duplex Ultrasound (DUS).
Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.
Timepoint [1] 0 0
12 months post-index procedure
Primary outcome [2] 0 0
Number of Participants With Freedom From Major Adverse Events (MAEs) - Freedom from major adverse events (MAEs) defined as: Target Vessel Revascularization; Device and/or procedure related death; Major amputation of target limb; Pulmonary Embolism which is clinically important; Vascular injury requiring surgical/endovascular intervention; Embolization /migration of stent; Device or procedure related acute DVT involving the treated limb.
Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.
Timepoint [2] 0 0
30 days post-index procedure
Secondary outcome [1] 0 0
Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months - The Venous Clinical Severity Score (VCSS) system includes 10 clinical descriptions (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulceration, size of active ulceration. and level of compliance with medical compression therapy), scored from 0 to 3 (total possible score, 30) with 0 means absent, 1 means mild, 2 means moderate and 3 means severe. Total VCSS is the sum of all VCSS assessment scores from categories for a given time point. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for Intent-to-Treat (ITT) subjects. Lower values represent a better outcome, that is, a level of pain less than that experienced at baseline.
Timepoint [1] 0 0
Evaluation at 12 months post-index procedure
Secondary outcome [2] 0 0
Endpoint With Hypothesis Testing: Index of Quality of Life (QoL) From Baseline to 12 Months - The Quality of Life (QoL) assessment of Chronic Venous Insufficiency Questionnaire (CIVIC-20) is a 20-item questionnaire which provides a global index and an outline of 4 QoL dimensions - pain (4 items), physical (4 items), psychological (9 items) and social (4 items). Items are scored on a scale from 1 to 5. A low score corresponds to greater patient comfort. Total CIVIQ-20 score is the sum of all 20-item scores The score of each dimension was obtained by adding up the scores of each constituent item within that dimension. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for evaluable ITT subjects. Lower values represent a better outcome, that is, a better QoL than that experienced at baseline.
Timepoint [2] 0 0
Evaluation at 12 months post-index procedure
Secondary outcome [3] 0 0
Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure - Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) Classification is a system that describes a doctor's physical exam findings for vein problem(s), the cause of the problem(s), the location in the leg, and the mechanism responsible for the manifestation of the vein problem. For Clinical classification, the clinical components indicates disease severity, ranging from none (0 points) to active ulcers (6 points).For each category of Etiology, Anatomy, and Pathophysiology classifications, at each time point, frequency of each category is reported. Subsequent clinical study reports will present CEAP at 24 and 36-months follow-up. Changes from baseline measures to given time points are presented. Lower mean scores represent an improvement from baseline measure.
Timepoint [3] 0 0
Evaluation through 30 day, 6 months and 12 months post index procedure
Secondary outcome [4] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Acute Technical Success - Acute technical success is defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator.
Timepoint [4] 0 0
At time of Index Procedure
Secondary outcome [5] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Acute Procedure Success (ITT Subjects) - Technical success is defined as no major adverse events experienced between index procedure and discharge
Timepoint [5] 0 0
Less than 30 days post index procedure
Secondary outcome [6] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Lesion Success (ITT Subjects) - Lesion Success is defined as the attainment of less or equal to 50% residual stenosis at the conclusion of the index procedure.
Timepoint [6] 0 0
At the conclusion of index procedure
Secondary outcome [7] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects) - Freedom from Target Lesion Revascularization (TLR) through 30 days is specific to the first revascularization procedure of the target lesion.
Timepoint [7] 0 0
Evaluation throrugh 30 day, 6 months and 12 months post index procedure
Secondary outcome [8] 0 0
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects) - Freedom from Target Vessel Revascularization (TVR) is defined as the first revascularization procedure of the target vessel, as determined by an Independent Core Lab. Freedom from Target Lesion Revascularization (TLR) and Freedom from TVR results are the same through the 12 month analysis as all TLRs were also TVRs in this case.
Timepoint [8] 0 0
Evaluation through 30 days, 6 months and 12 months post index procedure
Secondary outcome [9] 0 0
Endpoint Without Hypothesis Testing: Number of Participants Without Device Stent Fracture at 12 Months Follow-Up - Stents were evaluated at the 12 month follow-up for fracture analysis. Evaluable ITT subjects are included in this analysis.
Timepoint [9] 0 0
Evaluation at 12 months post-index procedure

Eligibility
Key inclusion criteria
1. The subject provides written informed consent using an Informed Consent Form approved
by Ethics Committee/ Institutional Review Board for the site.

2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.

3. The subject is a male or non-pregnant female = 18 years old with an expected lifespan
sufficient to allow for completion of all study procedures.

4. The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral
"venous segments".

5. The subject has symptomatic venous outflow obstruction (non-malignant) in iliofemoral
venous segments(Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) "C" = 3 or VCSS
pain score of = 2).

6. The subject is able and willing to comply with any required medication regimen.

7. The reference vessel diameters are between 7mm and 19 mm.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject is unable or unwilling to provide written informed consent, or is unable or
unwilling to conform to the study protocol follow-up procedures and visits.

2. Subject is or plans to become pregnant during the study.

3. Subject has contralateral disease of the common femoral vein, external iliac vein,
common iliac vein, or any combination thereof and does not meet the venous outflow
obstruction requirement or has a malignant obstruction.

4. The subject is asymptomatic, has a CEAP "C" <3, or a VCSS pain score of <2.

5. The subject has a venous obstruction that extends into the inferior vena cava (IVC) or
below the level of the lesser trochanter.

6. The subject has a known uncorrectable bleeding diathesis or active coagulopathy.

7. The subject has a known allergy or sensitivity to Nickel or Titanium or intolerance to
antiplatelet, anticoagulant or thrombolytic medications medications required per the
protocol

8. The subject has a known allergy or sensitivity to contrast media, which cannot be
adequately pre-medicated.

9. The subject has any planned surgical interventions within 30 days prior to, or within
30 days after the planned study procedure.

10. The subject has a lesion or occlusion which cannot be traversed with a guidewire.

11. The subject has had prior stenting in the target vessel.

12. The subject has iliofemoral venous segments unsuitable for treatment with available
sizes of study devices.

13. The subject has another medical condition, which may cause him/her to be non-compliant
with the protocol, confound the data interpretation, or is associated with a life
expectancy insufficient to allow completion of study procedures and follow ups.

14. The subject is currently participating in an investigational drug, biologic, or
another device study.

15. The subject is currently on dialysis or has a serum creatinine =2.5mg/dl.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
JMLS Medical Services PTY LTDT/A PERTH INST. of VASCULAR RESEARCH - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
United States of America
State/province [10] 0 0
West Virginia
Country [11] 0 0
Germany
State/province [11] 0 0
Aachen
Country [12] 0 0
Germany
State/province [12] 0 0
Arnsberg
Country [13] 0 0
Germany
State/province [13] 0 0
Bad Krozingen
Country [14] 0 0
Ireland
State/province [14] 0 0
Gaillimh
Country [15] 0 0
Netherlands
State/province [15] 0 0
Maastricht
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
C. R. Bard
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The BARD® Venovo™ Venous Stent Study is a non-randomized clinical study intended to collect
confirmatory evidence of the safety and effectiveness of the Venous Stent for the treatment
of iliofemoral occlusive disease.
Trial website
https://clinicaltrials.gov/show/NCT02655887
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Dake, MD
Address 0 0
Lead Principal Investigator
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications